Manager, eSOurce Architecture & Clinical Systems

Johnson County Clintrials LLC; Lenexa (KS); On-site; USD 110,000 - 140,000; Full time

Job summary

Johnson County Clintrials LLC is seeking a Manager, eSource Architecture & Clinical Systems to lead a team responsible for the design, development, and support of electronic source documentation systems.

You will develop and implement eSource strategies aligned with regulatory requirements and sponsor expectations, ensuring GCP compliance and high data quality across studies. The role involves cross-functional collaboration, continuous process improvement, and mentoring a high-performance team.

Qualifications

• Bachelor's degree in Life Sciences, Healthcare, Information Technology or related field.
• Proven experience in clinical systems, eSource architecture, or related roles within a clinical research environment.
• Strong understanding of federal regulations, GCP guidelines, and sponsor requirements related to electronic source documentation.
• Demonstrated leadership skills with experience managing technical teams.
• Excellent project management, strategic planning, and problem-solving abilities.
• Effective communication skills, capable of collaborating across diverse teams and stakeholders.
• Knowledge of clinical trial processes, data management, and regulatory compliance.
• Ability to adapt to evolving technologies and industry standards.

Responsibilities

• Lead and oversee a team of eSource Architects responsible for design, development, and support of electronic source documentation systems.
• Develop and implement eSource strategies aligned with organizational goals, regulatory requirements, and sponsor expectations.
• Ensure all systems and processes comply with federal regulations, GCP standards, and organizational policies.
• Collaborate with cross-functional teams to optimize study startup timelines, improve site adoption, and enhance data quality.
• Provide quality oversight and continuous process improvement to ensure operational excellence.
• Support clinical research operations by developing scalable processes, training, and best practices.
• Monitor team performance, provide mentorship, and foster a culture of innovation and accountability.
• Maintain up-to-date knowledge of regulatory changes, industry trends, and emerging technologies related to electronic source documentation.

Skills

Leadership

Project management

Communication

Strategic planning

Problem solving

Cross-functional collaboration

Regulatory knowledge

Adaptability to new tech

Education

Bachelor's degree in Life Sciences, Healthcare, IT

Advanced degree preferred

Tools

EDC systems

Regulatory compliance tools

Job description

Manager, eSource Architecture & Clinical Systems

Key Responsibilities:

• - Lead and oversee a team of eSource Architects responsible for the design, development, and support of electronic source documentation systems.
• - Develop and implement eSource strategies aligned with organizational goals, regulatory requirements, and sponsor expectations.
• - Ensure all systems and processes comply with federal regulations, Good Clinical Practice (GCP) standards, and organizational policies.
• - Collaborate with cross-functional teams to optimize study startup timelines, improve site adoption, and enhance data quality.
• - Provide quality oversight and continuous process improvement to ensure operational excellence.
• - Support clinical research operations by developing scalable processes, training, and best practices.
• - Monitor team performance, provide mentorship, and foster a culture of innovation and accountability.
• - Maintain up-to-date knowledge of regulatory changes, industry trends, and emerging technologies related to electronic source documentation.

Skills and Qualifications:

• - Bachelor's degree in Life Sciences, Healthcare, Information Technology, or a related field; advanced degree preferred.
• - Proven experience in clinical systems, eSource architecture, or related roles within a clinical research environment.
• - Strong understanding of federal regulations, GCP guidelines, and sponsor requirements related to electronic source documentation.
• - Demonstrated leadership skills with experience managing technical teams.
• - Excellent project management, strategic planning, and problem-solving abilities.
• - Effective communication skills, capable of collaborating across diverse teams and stakeholders.
• - Knowledge of clinical trial processes, data management, and regulatory compliance.
• - Ability to adapt to evolving technologies and industry standards.

At our organization, we foster a collaborative and innovative culture that values continuous learning and professional growth. We are committed to supporting our team members with comprehensive benefits and opportunities to advance your career in the rapidly evolving field of clinical research technology.